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Improving Consent and Survey Procedures for Young MSM in Web-based HIV Prevention

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ClinicalTrials.gov Identifier: NCT02139566
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : January 15, 2016
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Patrick S Sullivan, Emory University

Brief Summary:
A two-part study to test the efficacy of alternative consent procedures and the efficacy of alternative methods to improve survey completion.

Condition or disease Intervention/treatment Phase
Healthy Behavioral: Video consent (high-tech) Behavioral: Video consent (low-tech) Behavioral: FAQ format consent Behavioral: Standard consent Behavioral: PDF informed consent document Not Applicable

Detailed Description:

Men who have sex with men are the risk population most heavily impacted by HIV in the United States by any measure; in 2009, at least 61% of new HIV infections were estimated to have occurred in MSM. MSM are experiencing an increase in HIV transmission that has been occurring since at least 1990, and accelerated in multiple North American and European countries from 2000-2005. The expansion of the HIV epidemic has been proposed to be attributable, in part, to the extent to which the internet has facilitated sexual connectivity among MSM.

Researchers have attempted to reach MSM for HIV prevention research and intervention on the internet. In the past 10 years, there has been a proliferation of internet surveys and HIV research studies among men who have sex with men that utilize the internet for data collection and, in some cases, the delivery of HIV prevention content. The development of internet-based interventions has been recently identified as especially promising because of its potential for scalability. However, there are also important limitations to internet-based data collections and prevention studies. The most important of these relate to representativeness and opportunities to introduce bias to data collections and differences in access to and use of internet among different subgroups of MSM. Equally important, although less discussed, are the unique ethical and human research protections challenges posed by online sexual health prevention studies.

The investigators will conduct a series of experiments that will result in improved knowledge of how to conduct internet-based HIV prevention research with MSM in ways that improve the protection of human subjects and decrease biases in data collections. The design will consist of preparatory online qualitative research with up to 100 MSM, followed by two cross-sectional randomized controlled trials of MSM recruited online; a total of 2440 MSM will be enrolled in the two randomized quantitative studies (1,440 in Study 1 to determine optimal methods to provide informed consent, online, and 1000 in Study 2 to determine how to best improve retention in online surveys). About 2440 men will be enrolled in the study in total. This summary describes Study 1; a separate submission will be completed for Study 2.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2405 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Improving Consent and Survey Procedures for Young MSM in Web-based HIV Prevention
Study Start Date : July 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Hi-tech video consent
This group will be shown a professionally animated video that presents the major components of the informed consent document. Intervention is Video Consent (high-tech) PDF informed consent document.
Behavioral: Video consent (high-tech)
Consent provided by an animated video with captions

Behavioral: PDF informed consent document
A PDF of the full consent document will be available for download, through hyperlink on the consent page. This is provided for video (low-tech), video (high-tech), FAQ format, and standard informed consent.

Experimental: Low-tech video consent
Participants in this arm will be provided with informed consent information through viewing a "talking head" video produced by a non-professional presenter, with widely available and inexpensive video equipment. Intervention is "video consent (low-tech)", PDF informed consent document.
Behavioral: Video consent (low-tech)
This consent is a video production of the informed consent information, taped using a staff member with basic video equipment.

Behavioral: PDF informed consent document
A PDF of the full consent document will be available for download, through hyperlink on the consent page. This is provided for video (low-tech), video (high-tech), FAQ format, and standard informed consent.

Experimental: FAQ consent
Participants in this arm will be provided with informed consent content through an interactive "frequently asked questions" format, in which the participant will click on a question and be shown text that provides an answer to that question. Major informed consent topics will have one or more question and answer pairs. Intervention is "FAQ format consent", PDF informed consent document
Behavioral: FAQ format consent
This consent modality will present the basic information from the informed consent in an interactive, "frequently asked questions" format. Upon clicking each question, the participant will be shown a short text response to that question.

Behavioral: PDF informed consent document
A PDF of the full consent document will be available for download, through hyperlink on the consent page. This is provided for video (low-tech), video (high-tech), FAQ format, and standard informed consent.

Active Comparator: Standard consent process
Participants in this arm will be provided with informed consent content by being shown a standard informed consent document in a scrolling window within the browser window, PDF informed consent document
Behavioral: Standard consent
The standard consent form will present the full informed consent document in a scrolling text window within the browser window. Participants will be asked to review the document online.

Behavioral: PDF informed consent document
A PDF of the full consent document will be available for download, through hyperlink on the consent page. This is provided for video (low-tech), video (high-tech), FAQ format, and standard informed consent.




Primary Outcome Measures :
  1. Knowledge of Consent Information [ Time Frame: At baseline (time zero) ]
    Correct knowledge of key aspects of the consent document will be operationalized by a count of the correctly answered consent recall items placed at the end of the survey, expressed as the number of correct items as a continuous measure.


Secondary Outcome Measures :
  1. Proportion of eligible men who consent [ Time Frame: Time of informed consent (baseline) ]
    The proportion of eligible men who consent to participate in the study; this secondary outcome is applicable only to the randomized study of alternative forms of informed consent administration.

  2. Engagement with Consent Information [ Time Frame: Time of consent ]
    We will measure engagement with the consent information by recording the amount of time a participant spends on the consent page before clicking to the first page of the survey.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ages 18-34
  • have had sex with another man in the past 12 months

Exclusion Criteria:

  • female, transgender
  • younger than 18 years old
  • older than 34 years old
  • have not had sex with a man in the past 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139566


Locations
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United States, Georgia
Rollins School of Public Health, Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Patrick S Sullivan, PhD Emory University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Patrick S Sullivan, Professor, Emory University
ClinicalTrials.gov Identifier: NCT02139566    
Other Study ID Numbers: IRB00065333
1R21HD074502-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016